An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study

Status: Recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Use of adequate contraception for females of childbearing potential

• Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)

• Documented medical history compatible with chronic HCV

• Either no liver cirrhosis or with compensated liver cirrhosis

• If HIV-1-positive, must meet the following 2 criteria:

‣ Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and plasma HIV-1 RNA \<LLOQ

⁃ Suitable ARV treatment and not taking any contraindicated medications

Locations
Other Locations
France
Atea Study Site
RECRUITING
Clermont-ferrand
Atea Study Site
RECRUITING
Clichy
Atea Study Site
RECRUITING
Montpellier
Atea Study Site
RECRUITING
Strasbourg
Germany
Atea Study Site
RECRUITING
Frankfurt Am Main
Atea Study Site
RECRUITING
Hamburg
Atea Study Site
RECRUITING
Leipzig
India
Atea Study Site
RECRUITING
Belagavi
Atea Study Site
RECRUITING
Hyderabad
Atea Study Site
RECRUITING
Kanpur
Atea Study Site
RECRUITING
Kolkata
Atea Study Site
RECRUITING
Lucknow
Atea Study Site
RECRUITING
Nagpur
Atea Study Site
RECRUITING
Pune
Atea Study Site
RECRUITING
Rajkot
Atea Study Site
RECRUITING
Surat
Atea Study Site
RECRUITING
Varanasi
Malaysia
Atea Study Site
RECRUITING
Kota Bharu
Atea Study Site
RECRUITING
Kota Bharu
Atea Study Site
RECRUITING
Kuala Lumpur
Atea Study Site
RECRUITING
Kuantan
Pakistan
Atea Study Site
RECRUITING
Islamabad
Atea Study Site
RECRUITING
Islamabad
Atea Study Site
RECRUITING
Karachi
Atea Study Site
RECRUITING
Karachi
Atea Study Site
RECRUITING
Karachi
Atea Study Site
RECRUITING
Lahore
Atea Study Site
RECRUITING
Lahore
Atea Study Site
RECRUITING
Lahore
Atea Study Site
RECRUITING
Peshawar
Atea Study Site
RECRUITING
Rawalpindi
Poland
Atea Study Site
RECRUITING
Kłodzko
Atea Study Site
RECRUITING
Mysłowice
Atea Study Site
RECRUITING
Wroclaw
Republic of Korea
Atea Study Site
RECRUITING
Busan
Atea Study Site
RECRUITING
Busan
Atea Study Site
RECRUITING
Seoul
Atea Study Site
RECRUITING
Seoul
Atea Study Site
RECRUITING
Yangsan
Republic of Moldova
Atea Clinical Study Site
RECRUITING
Chisinau
Romania
Atea Study Site
RECRUITING
Bucharest
Atea Study Site
RECRUITING
Bucharest
Atea Study Site
RECRUITING
Bucharest
Atea Study Site
RECRUITING
Bucharest
Atea Study Site
RECRUITING
Constanța
Atea Study Site
RECRUITING
Craiova
Atea Study Site
RECRUITING
Galati
Atea Study Site
RECRUITING
Iași
Atea Study Site
RECRUITING
Sibiu
Atea Study Site
RECRUITING
Suceava
South Africa
Atea Study Site
RECRUITING
Bloemfontein
Atea Study Site
RECRUITING
Brits
Atea Study Site
RECRUITING
Johannesburg
Atea Study Site
RECRUITING
Johannesburg
Atea Study Site
RECRUITING
Johannesburg
Atea Study Site
RECRUITING
Port Elizabeth
Atea Study Site
RECRUITING
Pretoria
Atea Study Site
RECRUITING
Somerset West
Spain
Atea Study Site
RECRUITING
Vigo
Thailand
Atea Study Site
RECRUITING
Bangkok
Atea Study Site
RECRUITING
Hat Yai
Atea Study Site
RECRUITING
Mueang Nonthaburi
Atea Study Site
RECRUITING
Mueang Nonthaburi
Atea Study Site
RECRUITING
Pathum Wan
Contact Information
Primary
Clinical Trials Administrator
ateaclinicaltrials@ateapharma.com
1-857-284-8891
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2027-03
Participants
Target number of participants: 880
Treatments
Experimental: Bemnifosbuvir - Ruzasvir (BEM/RZR)
Active_comparator: Sofosbuvir-Velpatasvir (SOF/VEL)
Related Therapeutic Areas
Sponsors
Leads: Atea Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov